1. Field of Invention
The present invention relates to a device for reminding a patient to take his next dose of medication as well as a carton container, which is intended especially for medication. More specifically, the invention provides medication packaging with a simple visual representation of the patient's dosage schedule for a particular medication, and when the next dose is due or when the last dose was taken.
2. Discussion of Prior Art
Devices and methods to help patients follow a medication regimen are not a new phenomenon. On Dec. 8, 1885, U.S. Pat. No. 332,208 was granted to J. S. Noel for a “TIME DOSE-INDICATOR FOR BOTTLES”, consisting of a series of dials and a window. Even at that time his invention offered new and useful improvements over previous designs. More complex and costlier devices and means are also described in the art. For example, U.S. Pat. No. 5,752,235 granted to Kehr, et al. on May 12, 1998 for an, “ELECTRONIC MEDICATION MONITORING AND DISPENSING METHOD” describes a device having a plurality of compartments for storing medication and an electrical signaling system to emit medication alert signals from time to time.
Other recent devices seek to replace commonly used containers with elaborate designs. For example, U.S. Pat. No. 5,482,163 granted to Kenneth L. Hoffman on Jan. 9, 1996 for a, “LAST EVENT INDICATOR” describes a device consisting of a cylindrical container and an expandable indicator ring disposed over the cylinder's outer surface. All embodiments of the invention would cost more than vials in use today and would necessitate the production of numerous sizes. The investment in tooling alone would be considerable.
Available specialized blister card and dial type medication packaging which include a plurality of pill cavities can offer a reminder by way of indicia referencing individual pill cavities. However, such packaging is relatively costly to produce and normally requires separate tooling for each pill size. Such packages are viable in a treatment area like contraception because of limited universal dosage regimens. That is usually not possible for other medications. The cost of the reminder is directly tied to the number of pills dispensed. Furthermore the space occupied by a method which positions each pill in a discrete separated location can be considerably more than bulk packaging. Loading such packages with medication is also more costly. These limitations have negatively impacted the increased use of such packaging.
Some reminder devices that work with standard medication containers exist in the art, however they do not seem to have become widely available. It is believed that these prior devices have shortcomings such as undue complexity, cost of manufacture, applicability to few containers and requirement of special skills. Failing to provide for simple customization by the patient or Pharmacist has also been an obstacle to acceptance, because it resulted in a device of limited application or necessitated the production of a great variety of devices. The devices, for the most part, also seem to be designed for use with prescription vials.
For example, a typical invention for use on vials, U.S. Pat. No. 3,996,879 granted to Vilma E. Walton on Dec. 14, 1976 for a, “REMINDER DEVICE FOR MEDICINE AND THE LIKE”, describes a device having an open ended collar that mounts on a cylindrical shaped container such as a vial. A display unit with windows is mounted on the collar. The display unit has a spring loaded and movable slide element to selectively cover a window and its associated notation. Because medication containers have various shapes and sizes, a wide variety of such devices would have to be manufactured. Both the collar and display unit, are molded and the display unit is very intricate, making the device costly to produce.
U.S. Pat. No. 6,032,609 granted to Van A. Luoma on Mar. 7, 2000 for a “DOSAGE INDICATOR MEDICINE CONTAINER” describes a system for permanently recording the taking of medication directly on a disk or strip. This record also serves to indicate if the medication was taken. The disk may be affixed to the top of a medication closure and the strip may be affixed to the wall surface of a medication container. A number of different possible ways to indicate the recording are described. All require appropriate indicia on the disk and strip and all require the patient to irreversibly mark a specific predetermined location on the disk and strip. Although not mentioned, the device could conceivably be affixed to a medication carton. In practice this device is not practical for use on small containers such as those commonly used for pharmaceutical packages. The device requires a discrete location relating to each dose and would quickly encounter a space issue for any dosage regimen that is not of very short duration. In addition, in order for the indicia to contain the required information, the printing could become very small and crowded. The inventor suggests stacking disks and strips one on another in cases where a single disk or strip may not be able to display all the dosage events for the medication in the container. This can become cumbersome and demands a certain degree of dexterity, which not all patients may have. Marking a disk or strip in an exact small area could be problematic and prone to irreversible errors. A significant number of patients who could most benefit from a reminder device, are in an age group that generally suffers from reduced vision and reduced dexterity, making correct use of the device difficult. Every self-monitored program is subject to human error and defeat. A permanent record does not necessarily offer any increased assurance of compliance over any other compliance aid. Furthermore, recording the taking of medication is not necessary in most cases. Given that this device relies on irreversible marking to record an event, customization by the Pharmacist or patient does not appear to be simple or practical.
U.S. Pat. No. 6,152,067 granted to Ronald Grant Mathison on Nov. 28, 2000 for a “MEDICATION DOSAGE REMINDER DEVICE” describes a device having a cruciform hub that attaches to a medication container and an annular dial. The dial is further pinned between the hub and the container by a portion of the hub, but is otherwise free to rotate about the hub. When the dial is rotated, a pointer on the hub and indicia on the dial co-operate to indicate a dosage time. Although not mentioned, the device could conceivably be affixed to a medication carton. The device requires a close fit between the hub and the dial aperture in order to operate properly. This would necessitate the use of highly flexible materials to permit assembly. The device then relies on material rigidity in order to pin and maintain the position of the dial. The requirement for such a delicate balance between competing properties imposes an extreme limit on the choice of suitable materials. In use, this reminder device is placed on a medication container by first securing the rear surface of the hub to the container by way of an adhesive strip that runs laterally from one end of the hub to the other. The longitudinal tabs are then deformed in order to slip both of them through the central aperture in the dial and then restored to substantially their original orientation. Given the small device size dictated by today's pharmaceutical packages, and given the necessary material properties, it would seem to require a fair degree of dexterity to mount the hub and then assemble the device on a flat carton surface. It would also seem to be difficult to make the longitudinal tabs, one of which acts as a pointer, lie in a plane that is parallel to the plane of the dial and the associated indicia. It appears as though it would further be difficult to take sufficient care to ensure that the pointer does not deflect or change planes in operation. In such a case accurate referencing of indicia on the dial could become difficult at best and dangerous at worst.
There is a definite need for improving what the medical profession calls “patient compliance”, but it is evident that to date, the inventive art has not adequately met the challenge. The more complex of these devises and systems offer far more features and control than what the vast majority of patients require. Their costs are also prohibitive. With the advancing average age of patients and their increased reliance on multiple concomitant self-administered medicines, there is a growing unfulfilled need for a simple, acceptable mass-market compliance aid. A device that is most likely to gain broad acceptance is one that conserves the current well established medication delivery packaging and one that compliments rather than changes dispensing and consumption procedures.
While considerable inventor attention has been focused on the need for an acceptable reminder device for medication delivered to the user in a prescription vial, other equally important medication packaging formats have been largely overlooked. It would be beneficial to patients if a medication reminder device could be included with all formats and packaging. These can include bottles, jars, syringes, tubes, inhalers, and standard blister cards to name a few. There is also an increasing trend, driven in part by the need to attract consumer attention, for manufacturers to further package already contained prescription and over the counter (OTC) products in an outer container or folding carton. The patient throughout the course of treatment generally retains this outer medication container because it serves as a convenient holder for the contents or, the Pharmacist has affixed the prescription label to it, a practice that is common.
While many shapes of cartons are available, virtually all have an exterior wall surface that includes a somewhat flat portion. Conventionally, this carton has the shape of a rectangular parallelepiped and comprises a sleeve portion consisting of four walls, which are interconnected by folding lines. End flaps are connected to the sleeve portion along folding lines in order to close the ends of the carton. Normally, one end of the carton is permanently closed, the end flaps being for example glued to one another. The other end of the carton is closed by means of a tuckin tab, which is connected along a folding line to one of the end flaps. Consequently, the carton can easily he opened and reclosed at this end, such that the patient can remove a blister pack or other contents from the carton. User instructions are generally enclosed in the form of a separate leaflet, which is placed inside the carton.
This kind of tubular carton is made from an essentially rectangular sheet blank having a sleeve-forming portion with four wall-forming panels arranged side by side and being interconnected by folding lines. A closure tab is connected along a folding line to a first wall-forming panel on one side of the sleeve-forming portion. When the carton is erected, the closure tab is engaged, for example by means of adhesive, with a second wall-forming panel on the other side of the sleeve-forming portion. The blank further comprises end flaps, which are connected along folding lines to both ends of the sleeve-forming portion.
These medication cartons are mass-produced in a wide variety of wall thickness and sizes that are customized to suit the individual medication being packaged. It would be beneficial to patients and advantageous to manufacturers to have a simple reminder device that could be associated with all standard medication cartons or to have a simple construction modification of all medication cartons that could be incorporated into the production process to accomplish the same end. A reminder device on the outside of the carton would even be useful in cases where immediate packaging has some form of reminder because it would obviate the need for the user to open the carton in order to make a determination.
A device, which could be attached to a somewhat flat portion of the exterior surface of the carton, could equally be attached to any container or article having a somewhat flat portion in its exterior surface. This could include a blister card package, a bottle, a lid etc. A simple construction modification could also possibly be incorporated into the production process of other containers or articles having a somewhat flat portion in their exterior surface to accomplish the same end.